Authorities in Australia are investigating a significant increase in **adverse event reports** associated with the medication **Vyvanse**, commonly prescribed for attention deficit hyperactivity disorder (ADHD). The **Therapeutic Goods Administration (TGA)** is currently examining a potential safety signal linked to the medication, which has seen a dramatic rise in notifications this year.
A spokesperson for the TGA confirmed that the investigation involves independent testing of Vyvanse through TGA Laboratories. “The investigation is the result of a recent increase in adverse event notifications relating to concerns about the quality, safety, and reduced effectiveness of the drug,” the spokesperson stated. They also emphasized that there are currently no compliance issues under investigation regarding the facilities manufacturing the product.
Reports of adverse events, including anxiety, ineffectiveness, and insomnia, have surged this year. While these reports do not confirm causation, the TGA noted that there were **320 adverse events** linked to Vyvanse in the first half of 2024, a stark contrast to just nine reports in the second half of 2023.
Manufacturing Changes and Reported Issues
The spike in notifications also includes **88 reports** of labeling issues, which were flagged earlier this year. One notable typo added an extra ‘S’ to the term ‘capsule,’ stating, “Each capsules contains 60mg lisdexamfetamine dimesilate.” Despite these labeling errors, **Takeda Pharmaceuticals Australia**, the supplier of Vyvanse, asserts that there have been no changes to the formulation or chemical composition of the medication following a manufacturing facility transition in 2024. “There have been no changes to the formulation,” a spokesperson for Takeda told the ABC. They insisted that Vyvanse is produced under stringent quality controls in compliance with the **Therapeutics Goods Act**.
The increase in adverse event reports coincides with a rise in ADHD diagnoses and treatment demand across Australia. **Ruth Limkin**, founder of **Banyans Healthcare**, highlighted a “staggering increase” in self-diagnosed ADHD cases. “We’ve seen a **500 percent increase** in people contacting us looking for treatment who have self-reported ADHD,” Limkin shared in an interview with Sky News Australia.
Rising Prescription Rates
Prescription rates for Vyvanse have been climbing steadily. Government data indicates that over **958,000 prescriptions** were written by public health workers in 2022, increasing to **1.4 million** in 2023, and reaching **1.8 million** in 2024. This trend reflects a broader societal shift toward recognizing and treating ADHD, although it raises concerns about the quality and effectiveness of the medications being prescribed.
As the TGA continues its investigation, stakeholders remain alert to the potential implications for patients relying on Vyvanse for ADHD management. The situation underscores the importance of monitoring medication safety and efficacy as prescription rates continue to rise.
